First New Enbrel® Biosimilar Approved by FDA

Sandoz received approval by the Food and Drug Administration to market its biosimilar version of Enbrel® on Tuesday, August 30th. The FDA is calling this agent etanercept-szzs. It is the first biosimilar for etanercept approved for use in the US.

Sandoz has branded the product Erelzi™, and it is indicated for each of the autoimmune disorders for which the originator is approved, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and placque psoriasis.

Under current law, Sandoz could start marketing its new product 180 days after the FDA approval, which would mean a Q1 2017 launch. However, the patent litigation that has plagued many of the biosimilar agents may well delay launch of this agent. On August 11, the US District Court issued an injunction that precludes any manufacturing, distribution, or marketing efforts by Sandoz. Interestingly, Sandoz consented to the preliminary injunction. The court case associated with this patent wrangling is not scheduled to be heard until April 2017, and the decision may take some time after this. One wonders (1) how much additional revenue Amgen may rack up through the court date and (2) if Sandoz will take a much more aggressive discounting stance than it did with its first biosimilar Zarxio®.